Wu Jun
2012
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Journal
Chinese Journal of Pharmaceutical Analysis
Abstract
Objective:To establish the method for content uniformity of compound dihydralazine Sulfate Tablets and evaluate the quality.Methods:The HPLC column was Aglient Eclipse XDB-CN column(250 mm×4.6 mm,5 μm);the mobile phase was acetonitrile-0.01 mol·L-1 Sodium Heptanesulfonate solution(adjust to pH 2.7 with 20% phosphoric Acid solution)(55∶ 45);the flow rate was 0.8 mL·min-1,the detection wavelength was 316 nm.Results:The linear range of Dihydralazine Sulfate was 34.38-343.8 mg·L-1(r=0.9999,n=6),the average recovery rate was 100.1%(RSD=0.70%).The linear range of Hydrochlorothiazide was 25.70-257.0 mg·L-1(r=0.9999,n=6),the average recovery rate was 100.9%(RSD=0.33%).Conclusion:The method is convenient,accurate,simple and feasible.It can be used as a method of quality control.